Differences in biomechanical stability using various fibrin glue compositions for mesh fixation in endoscopic inguinal hernia repair

Background

In hernia surgery, mesh fixation with fibrin glue instead of tacks and sutures can demonstrably reduce postoperative morbidity without increasing recurrence rates. In some cases there are significant differences in the biomechanical properties, depending on the functional structure of the meshes. Furthermore, there are various fibrin glue products on the market and these are used for mesh fixation. This study compared the fixation strength of fibrin glues in combination with various meshes.

Methods

Three different lightweight polypropylene meshes (TiMESH? light, ULTRAPRO?, Optilene^? LP) were tested. All meshes were fixed using 2?ml of each of the three different fibrin glues (TISSUCOL^?, QUIXIL^?, EVICEL^?) and tested for their biomechanical stability. The defect in the muscle tissue used was 45?mm for a mesh size of 10?×?15?cm. Measurements were conducted using a standardized stamp penetration test, while aiming not to use a fixation strength of less than 32?N.

Results

With TISSUCOL, the fixation of Optilene LP proved to be significantly better than that of TiMESH or ULTRAPRO (97.3 vs. 47.9 vs. 34.9?N, p?<?0.001). With EVICEL, it was possible to also achieve good tissue fixation for the ULTRAPRO mesh, while the results obtained for Optilene and TiMESH were relatively poorer [114.7 vs. 92.4?N (p?=?0.056), vs. 64.3?N (p?<?0.001)]. With QUIXIL, satisfactory results were obtained only for Optilene LP (43.6?N).

Conclusion

This study showed that there were significant differences in the fixation strength of different polypropylene meshes in combination with various fibrin glues. Experiments demonstrated that for each mesh there is an optimum combination with a particular fibrin glue with respect to the fixation strength. It must now be verified whether these results can be extrapolated to clinical practice.     

A systematic review of randomised control trials assessing mesh fixation in open inguinal hernia repair

Purpose

The technique for fixation of mesh has been attributed to adverse patient and surgical outcomes. Although this has been the subject of vigorous debate in laparoscopic hernia repair, the several methods of fixation in open, anterior inguinal hernia repair have seldom been reviewed. The aim of this systematic review was to determine whether there is any difference in patient-based (recurrence, post-operative pain, SSI, quality of life) or surgical outcomes (operative time, length of operative stay) with different fixation methods in open anterior inguinal hernioplasty.

Methods

A literature search was performed in PubMed, EMBASE and the Cochrane Library databases. Randomised clinical trials assessing more than one method of mesh fixation (or fixation versus no fixation) of mesh in adults (>18 years) in open, anterior inguinal hernia repair, with a minimum of 6-month follow-up and including at least one of the primary outcome measures (recurrence, chronic pain, surgical site infection) were included in the review. Secondary outcomes analysed included post-operative pain (within the first week), quality of life, operative time and length of hospital stay.

Results

Twelve randomised clinical trials, which included 1,992 primary inguinal hernia repairs, were eligible for inclusion. Four studies compared n-butyl-2 cyanoacrylate (NB2C) glues to sutures, two compared self-fixing meshes to sutures, four compared fibrin sealant to sutures, one compared tacks to sutures, and one compared absorbable sutures to non-absorbable sutures. The majority of the trials were rated as low or very low-quality studies. There was no significant difference in recurrence or surgical site infection rates between fixation methods. There was significant heterogeneity in the measurement of chronic pain. Three trials reported significantly lower rates of chronic pain with fibrin sealant or glue fixation compared to sutures. A further three studies reported lower pain rates within the first week with non-suture fixation techniques compared to suture fixation. A significant reduction in operative time, ranging form 6 to 17.9 min with non-suture fixation, was reported in five of the studies. Although infrequently measured, there were no significant differences in length of hospital stay or quality of life between fixation methods.

Conclusions

There is insufficient evidence to promote fibrin sealant, self-fixing meshes or NB2C glues ahead of suture fixation. However, these products have been shown to be at least substantially equivalent, and moderate-quality RCTs have suggested that both fibrin sealant and NB2C glues may have a beneficial effect on reducing immediate post-operative pain and chronic pain in at-risk populations, such as younger active patients. It will ultimately be up to surgeons and health-care policy makers to decide whether based on the limited evidence these products represent a worthwhile cost for their patients.     

Efficiency and safety of mesh fixation in laparoscopic inguinal hernia repair using n-butyl cyanoacrylate: long-term biocompatibility in over 1,300 mesh fixations

Introduction  

In adult patients, most inguinal hernias are treated by implanting a prosthetic mesh. To prevent mesh dislocation and thus recurrence, different types of fixation have been proposed. In contrast to penetrating fixation known to cause acute chronic pain, adhesive fixation is becoming increasingly popular as it reduces markedly the risk of injury and chronic pain. Apart from the biological sealants (e.g., fibrin glue), surgical adhesives include a group of synthetic glues and genetically engineered protein glues. For example, cyanoacrylate is used in various medical and veterinary indications due to its fast action, excellent bonding strength and low price.     

Influence of Type of Mesh Fixation in Endoscopic Totally Extraperitoneal Hernia Repair (TEP) on Long-term Quality of Life

Introduction

Laparoscopic total extraperitoneal mesh repair (TEP) of inguinal hernia has become well accepted with low recurrence and high patient satisfaction rates. However, inguinal pain has also been reported. Source of this pain has been suggested to be the fixation method, especially the use of tacks. Introduction of fibrin glue and absorbable tacks were suggested to lower chronic pain and inguinal discomfort rates. This study analyses the different methods of fixation.

Patients and Methods

201 patients were analysed. Primary end-points were patients’ satisfaction, health-related quality of life, and specific inguinal conditions (e.g. pulling, swelling, troubles at coughing). Secondary endpoints were duration of operation, length of hospital stay, and material costs.

Results

Fibrin glue was used in 101 patients and tacks in 100 patients, in 21 of those absorbable tacks. Patients were fully satisfied with the results in more than 90%, irrespective of the fixation method. Health-related quality of life along the SF-12^® questionnaire attested no differences. Inguinal pulling occurred significantly more often after fibrin glue (25.7 %) than after tack fixation (11 %; p = 0.026), whereas no differences in the other specific inguinal sensations occurred.

Conclusion

Mesh fixation in TEP can be performed either by tacks or by fibrin glue with similar long-term results concerning satisfaction, health-related quality of life, and pain. No advantage of fibrin glue could be found, in fact, a higher percentage of patients had inguinal pulling and burning sensations after the use of fibrin glue. The use of absorbable tacks showed no advantage.     

Staple versus fibrin glue fixation in laparoscopic total extraperitoneal repair of inguinal hernia: a systematic review and meta-analysis

Background

Fixation of mesh is typically performed to minimize risk of recurrence in laparoscopic inguinal hernia repair. Mesh fixation with staples has been implicated as a cause of chronic inguinal pain. Our study aim is to compare mesh fixation using a fibrin sealant versus staple fixation in laparoscopic inguinal hernia and compare outcomes for hernia recurrence and chronic inguinal pain.

Methods and procedures

PubMed was searched through December 2010 by use of specific search terms. Inclusion criteria were laparoscopic total extraperitoneal repair inguinal hernia repair, and comparison of both mesh fibrin glue fixation and mesh staple fixation. Primary outcomes were inguinal hernia recurrence and chronic inguinal pain. Secondary outcomes were operative time, seroma formation, hospital stay, and time to return to normal activity. Pooled odds ratios (OR) were calculated assuming random-effects models.

Results

Four studies were included in the review. A total of 662 repairs were included, of which 394 were mesh fixed by staples or tacks, versus 268 with mesh fixed by fibrin glue. There was no difference in inguinal hernia recurrence with fixation of mesh by staples/tacks versus fibrin glue [OR 2.13; 95% confidence interval (CI) 0.60–7.63]. Chronic inguinal pain (at 3 months) incidence was significantly higher with staple/tack fixation (OR 3.25; 95% CI 1.62–6.49). There was no significant difference in operative time, seroma formation, hospital stay, or time to return to normal activities.

Conclusions

The meta-analysis does not show an advantage of staple fixation of mesh over fibrin glue fixation in laparoscopic total extraperitoneal inguinal hernia repair. Because fibrin glue mesh fixation with laparoscopic inguinal hernia repair achieves similar hernia recurrence rates compared with staple/tack fixation, but decreased incidence of chronic inguinal pain, it may be the preferred technique.

     

Randomized clinical trial of fibrin glue versus tacked fixation in laparoscopic groin hernia repair

Background

Preliminary studies have indicated clinical advantages of mesh fixation using fibrin glue in transabdominal preperitoneal groin hernia repair (TAPP)  compared with tack fixation. The aim of this randomized double-blinded, controlled, clinical trial is to compare fibrin glue with tacks fixation of mesh during TAPP.

Methods

One hundred and twelve men with unilateral inguinal hernia were enrolled. Primary outcome was pain during coughing on postoperative day 1. Secondary outcomes were postoperative scores of pain at rest, discomfort, and fatigue (day 1 and cumulated day 0–3), incidence of moderate/severe nausea and/or vomiting, foreign-body sensation, and recurrence after 6 months. Outcome measures were assessed by visual analogue scale (VAS, 0–100 mm), verbal rating scale (no, light, moderate or severe) and numerical rating scales (NRS, 1–10).

Results

One hundred patients were available for analysis. The fibrin group (n = 50) had significantly less pain during coughing on day 1 compared with the tacks group (n = 50) [median 23 (range 0–80) vs 35 (2–100) mm] (p = 0.020). Moreover, day 1 scores and all cumulated scores of pain during rest, discomfort, and fatigue were significantly lower in the fibrin group compared with the tacks group (all p-values ≤ 0.02). There was no significant difference in the incidence of nausea and/or vomiting (p > 0.05) or recurrence (fibrin glue n = 2, tacks n = 0, p = 0.241). Incidence of foreign-body sensation was significantly lower in the fibrin group at 1 month (p = 0.006).

Conclusions

Fibrin glue compared with tacks fixation improved the early postoperative outcome after TAPP. The trial was registered at clinicaltrials.gov NCT01000116.     

Lower reoperation rates with the use of fibrin sealant versus tacks for mesh fixation

Background

Groin hernia repair may be associated with long-term complications such as chronic pain, believed to result from damage to regional nerves by tissue penetrating mesh fixation. Studies have shown that mesh fixation with fibrin sealant reduces the risk of these long-term complications, but data on recurrence and reoperation rates after the use of fibrin sealant compared with tacks are not available. This study aimed to determine whether fibrin sealant is a safe and feasible alternative to tacks with regard to reoperation rates after laparoscopic groin hernia repair.

Methods

The current study compared reoperation rates after laparoscopic groin hernia repair between fibrin sealant and tacks used for mesh fixation. The study used data collected prospectively from The National Danish Hernia Database and analyzed 8,314 laparoscopic groin hernia repairs for reoperation rates. Mesh fixation was performed with fibrin sealant (n = 784) or tacks (n = 7,530).

Results

The findings showed a significantly lower reoperation rate for the fibrin sealant than for the tacks (0.89 vs 2.94 %, p = 0.031). The median follow-up period was 17 months (range, 0–44 months) for the fibrin sealant group and 21 months (range, 0–44 months) for the tacks group.

Conclusions

Fibrin sealant was superior to tacks for mesh fixation in laparoscopic groin hernia repair with regard to reoperation rates. The study could not differentiate between different hernia defect sizes, and future studies should therefore explore whether the superior effect of fibrin sealant applies for all hernia types and sizes.     

Mesh fixation with fibrin sealant during endoscopic totally extraperitoneal inguinal hernia approach: a review of 640 repairs

Purpose

Endoscopic repair of inguinal hernia can decrease the incidence of chronic groin pain. Staple mesh fixation is the surgical technique preferentially used but may also cause residual pain. Although a substantial number of specialists advocate no mesh fixations, concerns are that this could lead to an increase in recurrence rates. This study aimed to assess the safety and the effectiveness of fibrin sealant, as an alternative technique to staple mesh fixation after totally extraperitoneal (TEP) inguinal hernia repair.

Methods

A total of 472 patients underwent elective TEP inguinal hernia repair between February 2005 and July 2011. Mesh fixation was achieved using fibrin sealant. Patients were reviewed postoperatively at Week 2, Week 6, and Month 6. Patient satisfaction was assessed in a subgroup of 116 patients using a comprehensive scoring system designed for hernia repairs, and pain was assessed using a standard Visual Analog pain Scale.

Results

No conversion to open surgery was observed. There were two cases of major morbidities and no mortality. Three months after surgery, only three patients (0.6 %) experienced chronic groin or testicular discomfort. At Week 6, 98.9 % of the patients were either satisfied or very satisfied with their outcome, and 96.8 % denied any residual pain. Finally, only six hernia recurrences (0.9 %) were reported, of which five occurred during the first months of the study.

Conclusions

Fibrin sealant is safe and reliable for mesh fixation of inguinal hernia during TEP repair with a very high satisfaction index and limited risk of developing chronic pain.     

Use of fibrin sealant (Tisseel/Tissucol) in hernia repair: a systematic review

Background

Abdominal wall and inguinal hernia repair are the most frequently performed surgical procedures in the United States and Europe. However, traditional methods of mesh fixation are associated with a number of problems including substantial risks of recurrence and of postoperative and chronic pain. The aim of this systematic review is to summarize the clinical safety and efficacy of Tisseel/Tissucol fibrin sealant for hernia mesh fixation.

Methods

A PubMed title/abstract search was conducted using the following terms: (fibrin glue OR fibrin sealant OR Tisseel OR Tissucol) AND hernia repair. The bibliographies of the publications identified in the search were reviewed for additional references.

Results

There were 36 Tisseel/Tissucol studies included in this review involving 5,993 patients undergoing surgery for hernia. In open repair of inguinal hernias, Tisseel compared favorably with traditional methods of mesh fixation, being associated with shorter operative times and hospital stays and a lower incidence of chronic pain. Similarly, after laparoscopic/endoscopic inguinal hernia repair, Tisseel/Tissucol was associated with less use of postoperative analgesics and less acute and chronic postoperative pain than tissue-penetrating mesh-fixation methods. Other end points of concern to surgeons and patients are the risks of inguinal hernia recurrence and of complications such as hematoma formation and intraoperative bleeding. Comparative studies show that Tisseel/Tissucol does not increase the risk of these outcomes and may, in fact, decrease the risk compared with tissue-penetrating fixation methods. When used in the repair of incisional hernias, Tisseel/Tissucol significantly decreased both postoperative morbidity and duration of hospital stay.

Conclusions

Clinical evidence published to date supports the use of Tisseel/Tissucol as an option for mesh fixation in open and laparoscopic/endoscopic repair of inguinal and incisional hernias. Guidelines of the International Endohernia Society recommend fibrin sealant mesh fixation, especially in inguinal hernia repair. Nonfixation is reserved for selected cases.     

A comparison of a bovine albumin/glutaraldehyde glue versus fibrin sealant for hernia mesh fixation in experimental onlay and IPOM repair in rats

Background

Research in hernia repair has targeted new atraumatic mesh fixation to reduce major complications such as chronic pain and adhesion formation. The efficacy and safety of two surgical adhesives, viz. Artiss^® (FS, fibrin sealant containing 4 IU thrombin) and Bioglue^® (AGG, bovine serum albumin/glutaraldehyde glue), were evaluated in this study. Primary study endpoints were tissue integration, dislocation, and adhesion formation. Foreign-body reaction formed the secondary study endpoint.

Methods

Twenty-four polypropylene meshes (VM, Vitamesh^®) were randomized to four groups (n = 6): two groups of onlay hernia repair (two meshes per animal) with mesh fixation by FS (O-FS) or by AGG (O-AGG), and two groups of IPOM repair (one mesh per animal) with mesh fixation by four sutures and FS (I-FS) or AGG (I-AGG). Eighteen rats underwent surgery. Follow-up was 30 days. Tissue integration, dislocation, seroma formation, inflammation, adhesion formation, and foreign-body reaction were assessed.

Results

Meshes fixed with FS (O-FS, I-FS) showed good tissue integration. No dislocation, seroma formation, or macroscopic signs of inflammation were detectable. Adhesion formation of I-FS was significantly milder compared with I-AGG (P = 0.024). A moderate foreign-body reaction without active inflammation was seen histologically in O-FS and I-FS groups. Samples fixed with AGG (O-AGG, I-AGG) showed extensive scar formation. No dislocation and no seroma formation were observed. All of these samples showed moderate to severe signs of inflammation with abscess formation in the six meshes of O-AGG. Histology underlined these findings.

Conclusions

The fibrin sealant adhesive showed very good overall results of the primary and secondary outcome parameters. FS is a recommendable atraumatic fixation tool for the surgical onlay technique. AGG provides high adhesive strength, but shows low biocompatibility. Persisting active inflammation was seen in both the O-AGG and I-AGG groups, not favoring its use for these indications.     

Internal plug mesh without fixation in laparoscopic total extraperitoneal (TEP) repair of inguinal hernias: a pilot study

Purpose

Mesh fixation is essential in laparoscopic total extraperitoneal (TEP) repair of inguinal hernia; however, fixation sometimes causes post-operative pain. This study investigated a novel method of laparoscopic TEP repair without mesh fixation.

Methods

This study reviewed data from about two-hundred and forty-one laparoscopic TEP repairs on 219 patients, which were performed between December 2004 and October 2005.

Results

There were no statistically significant differences in the recurrence rate, seroma formation, and hospital stay. However, the mean operation time was shorter in the internal plug mesh group than the fixation group (p = 0.009), and post-operative pain only occurred in 4 cases in the internal plug mesh group in comparison to 29 cases in the mesh fixation group (p = 0.014).

Conclusions

An internal plug mesh without fixation might reduce post-operative pain after laparoscopic TEP repair of an inguinal hernia. Internal plug mesh without fixation may be an alternative method in laparoscopic TEP repair, especially for those involving indirect hernias.     

Effectiveness and safety of n-butyl-2-cyanoacrylate medical adhesive for noninvasive patch fixation in laparoscopic inguinal hernia repair

Background

Our purpose was to compare the recurrence rate and other clinical outcomes of laparoscopic (LS) transabdominal preperitoneal (TAPP) inguinal hernia repair using n-butyl-2-cyanoacrylate (NBCA) for mesh fixation with those of no mesh fixation and mesh fixation with titanium spiral tacks (ST).

Methods

The medical records of patients who received LS TAPP inguinal hernia repair between 2009 and 2012 at our institution were reviewed. Patients were included if the received LS TAPP with either no mesh fixation, mesh fixation with NBCA only, fixation with ST only, or fixation with NBCA + ST. Outcome measures were operation time, postoperative length of stay, visual analogue scale (VAS) pain score 24 h after surgery, postoperative complications, and hernia recurrence.

Results

A total of 1,027 TAPP cases were included. In 552 cases, meshes were fixed with NBCA only, in 89 cases only ST were used, in 47 cases ST and NBCA were used, and in 339 cases meshes were not fixed. The groups were comparable with respect to demographic and clinical characteristics. No surgical complications occurred in any group. VAS pain scores were significantly lower in the nonfixation and NBCA only groups (1.4 ± 0.6 and 1.3 ± 0.6, respectively) than in the ST and NBCA + ST groups (2.2 ± 0.9 and 2.2 ± 0.7, respectively; P = 0.001). The mean follow-up duration was ~19 months. At the final follow-up, no wound infections or hernia recurrences had occurred in any of the groups. No occurrence of chronic pain was noted in the nonfixation and NBCA only groups, whereas two cases (2.2%) were noted in the ST group and one case (2.1%) in the NBCA + ST group (P = 0.005).

Conclusions

The use of NBCA medical adhesive for noninvasive patch fixation in laparoscopic hernia repair (TAPP) is effective and safe.     

Fibrin sealant in inguinal hernioplasty: an observational multicentre study in 1,201 patients

Purpose

A prospective, multicentre, observational study was undertaken to assess Tisseel^® fibrin sealant for atraumatic mesh fixation in inguinal hernia repair throughout France.

Methods

Surgeons recorded data on patients undergoing tension-free inguinal hernioplasty with mesh fixation with Tisseel^®, regardless of the hernioplasty technique used. Assessments were made at 2 days and 1 month after surgery. Data on local complications, operation times and ease of product use were collected.

Results

In total, 1,201 patients were recruited (90% men, mean age 57 years), among which 526 procedures were performed using open techniques and 675 using laparoscopic repairs. Local complications occurred in 4.7% of patients: 3.0% haematoma, 1.4% seroma, 0.3% recurrence. The mean visual analogue scale (VAS)-rated pain scores were 3.2 pre-operatively, 2.3 immediately after surgery and 1.8 at 1 month. Surgeons rated the product as very easy to use.

Conclusions

Tisseel^® fibrin sealant appears to be a well-tolerated and easy-to-use alternative to traditional, tissue-penetrating devices for mesh fixation in hernia repair techniques.     

Open tension-free Lichtenstein repair of inguinal hernia: use of fibrin glue versus sutures for mesh fixation

Purpose

To investigate pain and other complications following inguinal hernioplasty performed by the Lichtenstein technique with mesh fixation by fibrin glue or sutures.

Methods

Five hundred and twenty patients were enrolled in this 12-month observational multicenter study and received either sutures or fibrin glue (Tissucol^?/Tisseel^?) based on the preference of the surgeon. Pain, numbness, discomfort, recurrence, and other complications were assessed postoperatively and at 1, 3, 6, and 12?months. Pain intensity was assessed by a visual analog scale (VAS; 0 [no pain] to 10 [worst pain]).

Results

One hundred and seventy-one patients received sutures and 349 received fibrin glue. During the early postoperative phase, 87.4% of patients in the fibrin glue group and 76.6% of patients in the sutures group were complication-free (P?=?0.001). Patients who received fibrin glue were also less likely to experience hematoma/ecchymosis than those in the suture group (both P?=?0.001). The mean pain score was significantly lower in the fibrin group than the sutures group (2.5 vs. 3.2, P?<?0.001). At 1?month, significantly fewer patients in the fibrin glue group reported pain, numbness, and discomfort compared with patients in the sutures group (all P?<?0.05). Fibrin glue patients also experienced less intense pain (0.6 vs. 1.2; P?=?0.001). By 3?months, the between-group differences had disappeared, except for numbness, which was more prevalent in the sutures group. By 12?months, very few patients reported complications.

Conclusions

Tissucol fibrin glue for mesh fixation in the Lichtenstein repair of inguinal hernia shows advantages over sutures, including lower incidence of complications such as pain, numbness, and discomfort, and should be considered as a first-line option for mesh fixation in hernioplasty.     

Fibrin sealant for mesh fixation in laparoscopic umbilical hernia repair: 1-year results of a randomized controlled double-blinded study

Purpose

Fibrin sealant for mesh fixation has significant positive effects on early outcome after laparoscopic ventral hernia repair (LVHR) compared with titanium tacks. Whether fibrin sealant fixation also results in better long-term outcome is unknown.

Methods

We performed a randomized controlled trial including patients with umbilical hernia defects from 1.5 to 5 cm at three Danish hernia centres. We used a 12 cm circular mesh. Participants were randomized to fibrin sealant or titanium tack fixation. Patients were seen in the outpatient clinic at 1 and 12 months follow-up.

Results

Forty patients were included of whom 34 were available for intention to treat analysis after 1 year. There were no significant differences in pain, discomfort, fatigue, satisfaction or quality of life between the two groups at the 1-year follow-up. Five patients (26 %) in the fibrin sealant group and one (6 %) in the tack group were diagnosed with a recurrence at the 1-year follow-up (p = 0.182) (overall recurrence rate 17 %). Hernia defects in patients with recurrence were significantly larger than in those without recurrence (median 4.0 vs. 2.8 cm, p = 0.009).

Conclusion

Patients with larger hernia defects and fibrin sealant mesh fixation had higher recurrence rates than expected, although the study was not powered for assessment of recurrence. There was no significant difference between groups in any parameters after the 1-year follow-up. The beneficial effects of mesh fixation with fibrin sealant on early outcome warrant further studies on optimization of the surgical technique to prevent recurrence.     

A technique for placement of a bioabsorbable prosthesis with fibrin glue fixation for reinforcement of the crural closure during hiatal hernia repair

Introduction

Level 1 data suggest that mesh reinforcement of the crural closure for hiatal hernia repair decreases the recurrence of hernia. The fear of erosion of the prosthetic into the esophagus has kept the use of mesh for hiatal hernia repair from becoming routine. A recent study found several cases of esophageal stenosis/erosion from the use of a biologic mesh. For these reasons, we evaluated a new resorptive prosthetic and new method of fixation of the prosthetic for crural reinforcement during hiatal hernia repair.

Methods

From February 2009 until December 2010, 70 patients underwent hiatal hernia repair using a synthetic bioabsorbable prosthetic made of polglycolide and teimethylene carbonate (Gore BioA Tissue Reinforcement?, Flagstaff, AZ). There were 48 patients with paraesophageal hiatal hernias and 22 with large sliding hiatal hernias. In this study, a square piece of mesh just the size to cover the crural closure only was utilized. Fibrin glue (Tisseel?) was applied over the suture closure of the crura, the mesh was then placed over the glue and held in place for several seconds, and then more fibrin glue was applied on top of the mesh.

Results

The new bioabsorbable polymer mesh was readily placed through a 10-mm trocar, had good handling characteristics laparoscopically, and no pre-operative preparation was required of the prosthetic. The material and the fibrin glue created a very substantial reinforcement of the crural closure, and the average time to place and fix the mesh was approximately 5 min. There were no short-term complications from the mesh, and no patient has had any significant post-operative sequelae.

Conclusion

Crural closure reinforcement during hiatal hernia repair can be done readily with this new bioabsorbable polymer–based mesh. Fibrin glue fixation of this new prosthetic can be done quickly and it creates a strong, fixed barrier that may decrease the chance of erosion. Further studies will need to be done to evaluate long-term efficacy and complications associated with its use.     

Comparison of the Clinical Outcome and Complications in Laparoscopic Hernia Repair of Inguinal Hernia With Mesh Fixation Using Fibrin Glue vs Tacker

Although laparoscopic repair offers a quick and less morbid way of treating hernias, complications like hematoma, seroma, neuralgia, recurrence, mesh infection, hydrocele, etc. are known. The present study was undertaken to compare various clinical outcomes between mesh fixation using fibrin glue and mesh fixation with tacker in a 3-months follow-up. One hundred patients aged 18 to 60 years having inguinal hernia admitted in Poona Hospital and Research Centre, Pune, between October 2012 and November 2014 for laparoscopic hernia surgery and ready to participate in this study were included. All of them underwent laparoscopic repair of hernia by total extra peritoneal (TEP) method following sample surgical protocol in all of them except for method of mesh fixation. Mean time calculated from insertion of the first trocar to beginning of skin suturing was 54.9 min in tacker group and 50.3 min in fibrin glue group with no statistically significant difference between the two. The incidence of urinary retention was significantly higher in tacker (34 %) as compared to fibrin glue (12 %) group. Incidence of hematoma was significantly higher in tacker group in 15-day follow-up, but there was no significant difference in hematoma formation at hernial sites in both groups after 15 days of follow-up. The incidence of neuralgia was significantly higher in the tacker group (24 %) compared with the fibrin glue group (2 %). Significantly, more number of people in the fibrin glue group 68 and 90 %, respectively, returned to work during 15 and 30 days follow-up as compared to the tacker group 46 and 64 %. Fibrin glue can be considered as an alternative to tacker for mesh fixation.     

Glue Versus Suture Fixation of Mesh During Open Repair of Inguinal Hernias: A Systematic Review and Meta-analysis

Background

Glue fixation of mesh has been explored for some time as a strategy for reducing postoperative chronic groin pain. Previous studies have come to different conclusions about the superiority of one method over another. We conducted a meta-analysis of randomized control trials comparing the performance of glue versus suture fixation of mesh in open inguinal hernioplasty.

Methods

Studies published up to November 2012 were searched using PubMed, EMBASE, MEDLINE, Cochrane Library, and the international standard randomised controlled trials number (ISRCTN) register. Mean differences (MDs) were derived from secondary continuous outcomes and pooled risk ratios (RRs) for categoric outcomes. Meta-analysis was conducted utilizing the random-effects and fixed-effects models as appropriate.

Results

Ten randomized controlled studies were selected, with a total of 1,623 patients. Glue fixation for open inguinal hernioplasty reduced chronic groin pain (RR 0.46, 95 % confidence interval (CI) 0.22–0.97), hematoma (RR 0.56, 95 % CI 0.34–0.90), acute postoperative pain (MD ?7.92, 95 % CI, ?13.17 to ?2.66), and time taken to return to normal activities (MD ?1.39, 95 % CI, ?2.58 to ?0.21). There was no evidence of an increase in adverse outcomes including recurrence with glue fixation (RR 0.83, 95 % CI 0.30–2.35).

Conclusions

Glue fixation of mesh for open inguinal hernioplasty is superior in many outcomes including the reduction of chronic groin pain. Glue fixation was not associated with an increased risk of hernia recurrence.     

Post-operative benefits of Tisseel®/Tissucol® for mesh fixation in patients undergoing Lichtenstein inguinal hernia repair: secondary results from the TIMELI trial

Purpose

The Tisseel/Tissucol for mesh fixation in Lichtenstein hernia repair (TIMELI) study showed that mesh fixation with human fibrin sealant during inguinal hernia repair significantly reduced moderate–severe complications of pain 12 months post-operatively compared with sutures. Further analyses may assist surgeons by investigating predictors of post-surgical complications and identifying patients that may benefit from Tisseel/Tissucol intervention.

Methods

Univariate and multivariate analyses identified risk factors for combined pain, numbness and groin discomfort (PND) visual analogue scale (VAS) score 12 months post-operatively. Variables tested were: fixation method, age, employment status, physical activity, nerve handling, PND VAS score at pre-operative visit and 1 week post-operatively. The effect of fixation technique on separate PND outcomes 12 months post-surgery was also assessed. Analyses included the intention-to-treat (ITT) population and a subpopulation with pre-operative PND VAS > 30 mm.

Results

316 patients were included in the ITT, with 130 patients in the subpopulation with pre-operative PND VAS > 30. Multivariate analysis identified mesh fixation with sutures, worsening pre-operative PND and worsening PND 1 week post-surgery as significant predictors of 12-month PND in the ITT population; mesh fixation with sutures was a significant predictor of 12-month PND in the pre-operative PND VAS > 30 subpopulation (p < 0.05). Mesh fixation with Tisseel/Tissucol resulted in significantly less numbness and a lower intensity of groin discomfort compared with sutures at 12 months; there was no difference in pain between the treatment groups.

Conclusions

Pre-operative discomfort may be an important predictor of post-operative pain, numbness and discomfort. Tisseel/Tissucol may improve long-term morbidity over conventional sutures in these patients.     

Early report of a randomized comparative clinical trial of Strattice™ reconstructive tissue matrix to lightweight synthetic mesh in the repair of inguinal hernias

Purpose

Biologic grafts are rarely used for inguinal herniorrhaphy. The aim of this study was to compare the clinical outcomes between patients undergoing a Lichtenstein’s hernioplasty with a porcine mesh versus a standard synthetic.

Methods

A prospective, randomized, double-blinded multicenter, evaluation of inguinal hernia repair was conducted between 2008 and 2010. Lichtenstein hernioplasty was performed using Strattice? or lightweight polypropylene (Ultrapro) mesh. Quality of life, pain, overall complication rate, and recurrence were measured.

Results

One hundred and seventy-two patients were randomized to Strattice? (n = 84) or Ultrapro (n = 88). At 3 months postoperatively, there were no differences on the occurrence or type of wound events [RR: 0.98 (95 % CI 0.52–1.86, p = 0.69), Strattice? (15 events) vs. Ultrapro (16 events)]. The mean level of impairment caused by the hernia, assessed by Activities Assessment Scale (AAS), significantly decreased postoperatively in both groups at 3 months (31 % Strattice? and 37 % Ultrapro). Patients in the Strattice group reported significantly less postoperative pain during postoperative days 1 through 3 compared to Ultrapro patients. However, the amount of postoperative pain at 3 months, as assessed by the mean worst pain score on a visual analog scale and the Brief Pain Index, was similar between groups (95 % CI 1.0–29.3). No hernia recurrences were observed in either group.

Conclusions

Strattice? is safe and effective in repairing inguinal hernia, with comparable intra-operative and early postoperative morbidity to synthetic mesh. Long-term follow-up is necessary in order to know whether the clinical outcomes of Strattice are equivalent to standard synthetic mesh in patients undergoing Lichtenstein’s hernioplasty.